Can a statin nanoparticle save sight in retinitis pigmentosa?
NCT ID NCT07774975
First seen Aug 19, 2026 · Last updated Aug 20, 2026 · Updated 1 time
Summary
This phase 1 trial tests whether an intravenous nanoparticle formulation of pitavastatin, called ULREA-PVS-NP, is safe in adults with retinitis pigmentosa, a rare inherited disease that causes progressive vision loss. The study aims to see if the treatment can reduce retinal inflammation and potentially slow photoreceptor degeneration. Participants receive either a single dose or repeated doses, with safety as the main focus.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ULREA-PVS-NP, a nanoparticle formulation containing pitavastatin, given intravenously
- What this could lead to
- If safe and effective, this could offer a new way to slow vision loss and preserve sight in people with retinitis pigmentosa.
- What could go wrong
- This is an early, small phase 1 trial focused on safety, not proof of benefit. The treatment may not work or could cause side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 21 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patients diagnosed with typical retinitis pigmentosa by two ophthalmologists according to the Clinical Practice Guidelines for Retinitis Pigmentosa (genomic diagnosis will not be performed). 2. Patients aged 18 years or older and 70 years or younger at the time of informed consent. 3. \* Patients with a mean retinal sensitivity of 10 dB or higher within the central 4 degrees (12 points) of the Humphrey 10-2 visual field. 4. \* Patients whose difference in mean retinal sensitivity (MD value) between two Humphrey 10-2 examinations at screening is within 3 dB. If the criteria are not met in the second examination, a third measurement will be performed within 14 days of the second examination, and the difference between the third measurement and the first or second measurement must be within 3 dB. 5. \* Patients with a foveal retinal thickness of 250 micrometer or less as measured by optical coherence tomography. \*At least one eye must meet criteria 3, 4, and 5. 6. Female patients of childbearing potential who agree to use appropriate contraception from the time of informed consent until 180 days after the last dose of the investigational product. 7. Male patients who agree to use appropriate contraception for 3 days from each administration of the investigational product. 8. Patients who can provide written informed consent. Exclusion Criteria: 1. Patients currently taking statins for hyperlipidemia. 2. Patients who have received helenien, unoprostone, or calcium channel blockers for the treatment of eye diseases within 30 days prior to informed consent. 3. Patients scheduled for ophthalmic surgery during the study period. 4. Patients with concomitant glaucoma or ocular hypertension. 5. Patients with concomitant uveitis or optic neuritis. 6. Patients with retinal lesions not attributable to retinitis pigmentosa (e.g., fundus hemorrhage, retinal edema, proliferative tissue, etc.) observed on fundus examination. 7. Patients with a history of hypersensitivity or severe adverse reactions to pitavastatin calcium or any component of the investigational product. 8. Patients with severe allergies or a history thereof. 9. Patients with severe renal impairment. 10. Patients with severe cardiac dysfunction or heart failure. 11. Patients with severe hepatic impairment. 12. Patients with biliary obstruction. 13. Patients with active inflammatory diseases or infections (e.g., active collagen disease, rheumatoid arthritis, ulcerative colitis, sepsis, etc.). 14. Patients with a history of cerebral hemorrhage, cerebral infarction, or ischemic heart disease within 6 months prior to informed consent. 15. Patients with hematological disorders (e.g., severe anemia, leukemia, aplastic anemia, etc.). 16. Patients with alcohol dependence, drug dependence, or mental disorders that may interfere with study participation. 17. Patients with concomitant malignant tumors or who have received treatment for malignant tumors within the past 3 years. 18. Patients currently receiving cyclosporine. 19. Patients currently receiving fibrate drugs (e.g., clofibrate, fenofibrate, bezafibrate, etc.) who cannot discontinue fibrate drugs from 3 days prior to the start of investigational product administration. 20. Patients currently receiving nicotinic acid, erythromycin, or rifampicin who cannot discontinue these drugs from 3 days prior to the start of investigational product administration. 21. Patients currently participating in other clinical trials or studies. 22. Pregnant women, women suspected of being pregnant, or lactating women. 23. Any other patient judged unsuitable by the principal investigator or sub-investigator.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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